TetraFlu

Inactivated quadrivalent flu vaccine (split virion).

A clear or slightly whitish opaque suspension.
This vaccine contains purified influenza virus HA antigen.
One dose of 0.5 mL of vaccine contains A/Sydney/5/2021 (H1N1)pdm09-like virus: A/Victoria/4897/2022 (IVR-238) 15 μg HA*.
A/Darwin/9/2021 (H3N2)-like virus: A/Darwin/9/2021 (SAN-010) 15 μg HA*.
B/Austria/1359417/2021-like virus: B/Austria/1359417/2021 (BVR-26) 15 μg HA*.
B/Phuket/3073/2013-like virus: B/Phuket/3073/2013 (BVR-1B) 15 μg HA*.
*Hemagglutinin.
This vaccine preparation has a pH of 6.8-8.0 and an osmolarity ratio to normal saline of approximately 1. The influenza virus strain is inoculated into the allantoic cavity of developing embryonated chicken egg. After incubation, the virus-containing allantoic fluid is collected and sucrose density gradient centrifugation is performed to isolate and concentrate the virus particles. Ether is added to lyse the virus particles and the resulting hemagglutinin (HA) fraction is recovered, inactivated by formalin, and diluted with a phosphate buffered solution to formulate a final suspension containing the required amount of HA of the virus strain.
The previously mentioned virus strain follows the WHO-recommended composition of influenza virus vaccines for use in the 2023/2024 influenza season in the northern hemisphere. The vaccine may contain traces of formaldehyde and polysorbate 80, which are added during the vaccine manufacturing process.
Excipients/Inactive Ingredients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate and water for injection.

Pharmacotherapeutic group: Influenza vaccine. ATC code: J07BB02.
Pharmacology: Pharmacodynamics: Seroprotection is generally obtained within 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies.
Clinical Studies: In a clinical study that evaluated the immunogenicity of single injection of TetraFlu or the licensed trivalent flu vaccine in healthy subjects aged over or equal to 18 years the HI antibody response is shown as follows. (See Tables 1 and 2.)

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Immune responses to each antigen of TetraFlu 21 days after vaccination in adults: See Tables 3 and 4.

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Immune responses to each antigen of TetraFlu at four weeks after the last vaccination in children: See Table 5.

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CHMP criteria: At least one of the previously mentioned serological assessments should meet the indicated requirements for assessment of seasonal flu vaccines.
Incidence of Solicited Local and Systemic Adverse Events within 7 Days of Vaccination: See Table 6.

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Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: A comparative toxicity study was conducted to compare the toxicity of AdimFlu trivalent influenza vaccine and TetraFlu influenza vaccine, at doses of 0.5 mL/animal, given by intramuscular injection to NZW rabbits three times at 2 weeks interval. All animals survived at the end of the study. There were no adverse effects observed in clinical observations, body weights, food consumption, ophthalmology, clinical pathology, gross necropsy and major organ histopathology.

Prophylaxis of influenza.
Tetraflu is indicated for active immunisation of children of age ≥3 years old and adults for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.

This vaccine is administered intramuscularly.
Dosage: For children of age ≥3 years old and for adults, one dose of 0.5 mL of vaccine is injected.
For children of age <9 years old previously unvaccinated with any seasonal flu vaccine, two doses should be administered.
Each dose should be administered at least 4 weeks apart.

No case of overdose has been reported.

Hypersensitivity to the active substances, to any of the excipients listed in Description or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, polysorbate 80 or with a history of hypersensitivity to previous influenza vaccinations.

Before vaccination, the recipient has to be enquired and visually examined, and an auscultation performed if necessary, to check the health status.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event or syncope (fainting) following the administration of the vaccine.
TetraFlu should under no circumstances be administered intravascularly.
Effects on Ability to Drive and Use Machines: TetraFlu has no or negligible influence on the ability to drive and use machines.

Animal reproduction studies have not been conducted with TetraFlu.
It is also not known whether TetraFlu can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TetraFlu should be given to a pregnant woman only if clearly needed.

Adverse events reported for TetraFlu in previous clinical trials are listed according to the following frequency categories: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100.
The local and systemic adverse events reported in the clinical trial in healthy subjects aged over 18 years are listed as follows: Nervous system disorders: Very common: headache.
Uncommon: drowsiness.
Gastrointestinal disorders: Common: nausea, vomiting.
Uncommon: diarrhoea.
Musculoskeletal and connective tissue disorders: Very common: muscle aches.
Uncommon: back soreness pain.
General disorders and administration site conditions: Very common: injection site pain, injection site swelling, malaise.
Common: injection site redness, injection site ecchymosis, decreased limb mobility, fever, chest tightness, face edema.
Uncommon: fatigue, injection site pruritus.
Respiratory, Thoracic and Mediastinal disorders: Very common: nasal congestion, cough, sore throat.
Common: respiratory distress.
Uncommon: chronic bronchitis.
Eye disorders: Common: eye redness.
Infections and infestations: Uncommon: nasopharyngitis, upper respiratory tract infection.
The local and systemic adverse events reported in the clinical trial in healthy children aged over 3 years are listed as follows: Nervous system disorders: Common: headache.
Gastrointestinal disorders: Common: nausea, vomiting, gastroenteritis, gastritis.
Musculoskeletal and connective tissue disorders: Very common: muscle aches (myalgia).
Common: dental caries.
General disorders and administration site conditions: Very common: injection site pain, injection site swelling, malaise.
Common: injection site redness, injection site ecchymosis, decreased limb mobility, fever, chest tightness, face edema.
Respiratory, Thoracic and Mediastinal disorders: Very common: nasal congestion, cough.
Common: respiratory distress, sore throat, bronchitis, pneumonia, epistaxis.
Eye disorders: Common: eye redness, conjunctivitis.
Infections and infestations: Very common: upper respiratory tract infection.
Common: nasopharyngitis, acute sinusitis, tonsillitis, pharyngitis, cellulitis, hand-foot-and-mouth disease, otitis media acute, herpangina.
Metabolism and nutrition disorders: Common: dehydration.
Skin and subcutaneous tissue disorders: Common: eczema.
Postmarketing experience: The adverse drug reactions listed as follows are not cases reported in previous TetraFlu trials; rather, they are cases of adverse reactions extracted from the leaflet of Adimflu trivalent influenza vaccine.
Blood and lymphatic system disorders: Thrombocytopenia, Lymphadenopathy.
Gastrointestinal disorders: Abdominal pain, Dysphagia, Anhepatia.
Metabolism and nutrition disorders: Lack of appetite.
General disorders and administration site conditions: Malaise, Influenza-like symptoms, Severe swelling.
Musculoskeletal and connective tissue disorders: Arthritis, Back pain, Pain of limbs.
Nervous system disorders: Neurologic abnormality (Facial palsy symptoms), Dizziness, Somnolence, Syncope, Nerves pain, Abnormal gait, Facial palsy, Hypesthesia, Dysesthesia, Seizure, Febrile Seizure, Guillain-Barre syndrome (GBS), Shake, Acute disseminated encephalomyelitis (ADEM), myelitis, neuritis.
Vascular disorders: Pale, Hot flashes, Vasculitis, Transient renal involvement (very rare).
Hypersensitivity: Shock, Asthma, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Rash.

Interactions with relation to immuno-suppressants such as Cyclosporin.
For individuals using immuno-suppressants, especially for long term or large quantity use, the expected effect of this vaccine may not be achieved.

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
Any unused product or waste material should be disposed of in accordance with local requirements.

Store in a refrigerator (2°C-8°C).
Do not freeze, a vaccine that has been frozen must not be used.
Keep the pre-filled syringe in the outer carton in order to protect from light.

Vaccines, Antisera & Immunologicals

J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.

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